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Use caution Medical device recall · FDA · Published January 30, 2023

DiaSorin Simplexa COVID-19 Direct Test Kits May Leak, Cause Invalid Results

DiaSorin recalls Simplexa COVID-19 Direct test kits with specific lot numbers due to potential leakage and cross-contamination risks, leading to invalid results and error codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1209-2023Medical deviceDiaSorin ›
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Contact the company

Recalling firmDiaSorin Molecular LLC11331 Valley View St · Cypress, CA 90630-5366
✎ GovInfoNow plain-language explainer

DiaSorin is recalling certain Simplexa COVID-19 Direct test kits that may leak, causing cross-contamination and invalid results. This could lead to inaccurate test outcomes if the kits are used. Read more at govinfonow.com/recall/58993-diasorin-simplexa-covid-19-direct-test-kits-may-leak-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/58993-diasorin-simplexa-covid-19-direct-test-kits-may-leak-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1209-2023

Cite this page

“DiaSorin Simplexa COVID-19 Direct Test Kits May Leak, Cause Invalid Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58993-diasorin-simplexa-covid-19-direct-test-kits-may-leak-cause. Based on FDA recall #Z-1209-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1209-2023%22&limit=1).

DiaSorin Molecular LLC recalled Simplexa COVID-19 Direct test kits due to potential leakage causing contamination and invalid results, the FDA announced on Jan. 30, 2023.

How to tell if you have it

  • Brand: DiaSorin
  • Product: Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
  • UDI-DI: 20816101027020
  • Lot codes: US13950, US14913, US13952, US13955, US13959, US13956, US13960, US13961, US13973, US13974, US14006, US14004, US14005, US14008, US14007, US14010, US14011, US14012, US14018, US14009, US14017, 15061N, X15475N, 13330N, 13331N, 13336N, 13968N, 14346N, 13967N
  • Reaction Mix lot codes: US14091, US14063, US14065, US14086, US14088, US14087, US14093, US14094, 13732, 13736, 13738, 15064, 13737, 14100, 14099, 14102, 14103, 15290, 14111, 14101, 14109, 13474N, X15479N, 14829N, 13751N, 13752N, 14036N, 14038N, 15082N
  • Units affected: 90,142

The hazard

Direct amplification Discs used with COVID-19 and Flu A/B & RSV assays may leak, causing contamination, cross-contamination, invalid results, and error codes.

Context

GovInfoNow's records show DiaSorin Molecular LLC has four other recalls on record since May 12, 2020. Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), GET TESTED D-Dimer Test Recall (Nov. 3, 2025), and Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).

How to tell if you have this one

Check the product's lot numbers: MOL4150/US13950, MOL4150/US14913, MOL4150/US13952, and other specific combinations listed in the recall notice. The kits include Reaction Mix with the same lot numbers.

  • Brand
    DiaSorin
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
Recall numberProduct, codes & lotsQuantity
Z-1209-2023Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2; UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot: MOL4150/US13950/MOL4151/US14091, MOL4150/US14913/MOL4151/US14063, MOL4150/US13952/MOL4151/US14065, MOL4150/US13955/MOL4151/US14086, MOL4150/US13959/MOL4151/US14088, MOL4150/US13956/MOL4151/US14087, MOL4150/US13960/MOL4151/US14093, MOL4150/US13961/MOL4151/US14094, MOL4150/US13973/MOL4151/US13732, MOL4150/US13974/MOL4151/US13736, MOL4150/US14006/MOL4151/US13738, MOL4150/US14004/MOL4151/US15064, MOL4150/US14005/MOL4151/US13737, MOL4150/US14008/MOL4151/US14100, MOL4150/US14007/MOL4151/US14099, MOL4150/US14010/MOL4151/US14102, MOL4150/US14011/MOL4151/US14103, MOL4150/US14012/MOL4151/US15290, MOL4150/US14018/MOL4151/US14111, MOL4150/US14009/MOL4151/US14101, MOL4150/US14017/MOL4151/US14109, MOL4150/15061N/MOL4151/13474N, MOL4150/X15475N/MOL4151/X15479N, MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/13967N/MOL4151/15082N90142
Z-1210-2023Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.; UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N4142
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Numbers

    Look for the lot numbers on the test kit packaging, which include specific combinations like MOL4150/US13950 or MOL4150/US14913.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 40 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Jan 30, 202312. FDA classified it Class II: Mar 3, 202323. Published in FDA’s Enforcement Report: Mar 15, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have the recalled kits?

Check the lot numbers on the packaging to see if your kit is affected. If it is, stop using it and contact DiaSorin for further instructions.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1209-2023 (January 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1209-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA